Friday, November 30, 2007

The recent report by the staff of the Senate Finance Committee on how GlaxoSmithKline tried to silence an early critic of Avandia who called attention to the drug's cardiovascular risk in 1999 has received some play in the press and among my esteemed fellow bloggers. I'm grateful to have had my attention called to the complete text of the Finance Committee report, as it raises some issues that may not have been fully exposed:

The basic story mirrors a previous case, Dr. Gurkirpal Singh of Stanford University, whom Merck tried to warn off from making critical statements about Vioxx's heart risks. Dr. John Buse is a distinguished research endocrinologist at the University of North Carolina. In 1999, Dr. Buse gave several talks at national conferences in which he warned of increased heart risks from the diabetes drug, Avandia--risks that this year led to the FDA requiring a black box warning, though it seems only fair to say that the case has not been definitively proven. GSK (back then, SmithKline Beecham) went into frenzied activity to shut him up. The consultations on how to manage the Buse problem went all the way to the CEO. Dr. Tachi Yamada, the company's research director (and now research head of the Gates Foundation) was directly involved in talking both with Dr. Buse and with his department chair. The end result was that the company drafted a letter which Buse referred to as a "clarification" and the company internal memos call a "retraction," and Buse effectively was silenced from making any more claims in public, though he continued to express his reservations in private.

So now we have the standard melodrama--GSK is the dastardly villain and Dr. Buse, plus all the patients who may have sufered from heart disease from taking Avandia, are the innocent victims. Or does this script hold water? Specifically, what made GSK so outraged that Buse had spoken up; and what made them think that they could succeed in reining him in?

A close reading of the documentary record that the Senate Committee staff compiled yields a number of facts. Dr. Buse was a consultant (presumably paid) for both SmithKline Beecham who made Avandia, and its competitor, Takeda-Lilly, that makes the closely related diabetes drug, Actos. (Actos seems to be sufficiently different in its chemical mechanism that it does not create the same heart risk that is seen with Avandia.) When for example SmithKline Beecham executives labeled Buse, in a series of internal e-mails, the "Avandia Renegade," were they referring to an independent academic stating his scientific views--or were they referring to the fact that one of their paid agents seemed to be turning on them? Or suggesting that Buse was a double agent who was now in the pay of their rivals and therefore tearing down Avandia to boost Actos sales?

In 2000, Buse seemed to be doing all he could to be conciliatory to the company. He even proposed to GSK that they give him money to sponsor a continuing medical education program about the use of all drugs in the same class, and that he had similarly approached Takeda for their financial support. He argued in his message that it would be a good thing for both company's marketing of their drugs that they were seen publicly as burying the hatchet, and that such a joint CME program had the potential to "grow interest in the class [of drugs] as a whole"--that is, that more doctors would prescribe both Avandia and Actos. An interesting posture, it now seems, for a doctor who is supposedly a hero for trying to call early attention to the risk of heart disease among patients taking Avandia.

In 2002 the internal GSK memos are singing a different tune. The company is worried because he was becoming the "most powerful Endocrinologist in the Carolinas," so that extending more olive branches (and money) in his direction would be a good move. GSK was trying to launch a new combination drug that combined Avandia with metformin, an old standby generic diabetes drug. In one memo a GSK official asks another, "It looks like marketing would like us to move forward using Dr. Buse as an investigator in the Avandamet program. Are you OK with this?" (That is truly an interesting question. Why is marketing, not research, deciding who should be an investigator in what is supposedly a research program? Say goodbye to any pretense that these firms are about science and not about sales.) The Senate Committee documents do not say if Buse became an Avandamet investigator and how much more he might have received in research grants or consulting fees.

I agree that it is bad when companies try to intimidate scientists to keep quiet about potential drug risks. But what about the academic physician-scientists, who think that they can ride the tiger and still stay in control? Dr. Buse, it appears, thought that on the one hand he could pocket his consulting fees (and perhaps speaker fees as well; we are not told) from these drug companies; and on the other hand could freely speak his mind as an academic scientist. His new owners told him in no uncertain terms that once the business deal had gone through, he had better remember who was calling the shots. Buse himself seems to have gotten the message as to who owns his opinion--when the press approached him recently to say something nasty about GSK, he refused, saying that the matter was over years ago, that they had apologized to him, and he was eager to let bygones be bygones.

My central message in HOOKED is: when we physicians are lacking in our own professional integrity, pointing fingers at the bad drug companies is hardly an adequate ethical response.

Monday, November 26, 2007

Dr. Danny Carlat, editor of the Carlat Psychiatry Report and keeper of another great blog on the problems with industry influence in medicine, has written a must-read article in the New York Times Magazine. I'll let his blog entry tell you about it and guide you to the article itself:

Very briefly, the article tells about Dr. Carlat's saga into and out of the world of paid drug company speaker--how he was initially wooed, wined and dined; how he rationalied the message he was giving to his medical colleagues (while pocketing a cool $30K in extra income); how he began to have doubts about the ethics of his role as he saw new research data showing that the drug he was shilling for was not all that great; and how he eventually regained his integrity and parted company with the company.

It may seem like piling on to pick any holes in Dr. Carlat's riveting and well-told story; and indeed he provides an excellent model of how good doctors ought to read the medical literature with a critical eye. Here I just want to add an angle that he appears to have left out.

Dr. Carlat initially assumed that he was "hired" by Wyeth for one reason--they wanted to "educate" other physicians in his area about why Effexor XR was the best antidepressant and why they should prescribe it as their first choice. As a physician he could command more credibility than a mere drug rep, and so of course his talks were of great value to the company. That explains why it was worth $30K to them to have his services.

In what way did he come to change his mind? At first, Dr. Carlat was himself a true believer--the data seemed to support Effexor's superiority. Later, he became a relative skeptic about Effexor, and perceived that as his enthusiasm for the drug slacked off, his Wyeth handlers were quick to point out his deficiencies as a speaker. In other words, his opinion changed about the ratio between real education and pure marketing contained in the talks he was giving.

What no reader of the article will take away is the possibility that the real reason Wyeth hired Dr. Carlat was to pay him $30K in bribes to get him to prescribe more Effexor in his own practice.

That sounds crazy, right? How can it be worth it to a drug firm to pay a single doc $30K just to prescribe more to his own patients? But consider two facts.

The first fact is sort of buried in Dr. Carlat's article. He mentions that we do not really know how many physicians are paid drug company speakers; but some data are consistent with it being 25 percent. A quarter of U.S. physicians are paid speakers? A quarter of us are really talented and entertaining educators? A quarter of us are so good with statistics that we can make sense of the most complicated research studies? Get real. If fully a quarter of us are out on the road giving talks, who's staying behind to hear the talks?

How about nurses? See my earlier post about what happened in Minnesota when they actually clamped down on the free dinners to docs (http://brodyhooked.blogspot.com/2007/10/if-you-dont-feed-them-they-wont-come.html). The drug companies could no longer get away with taking docs out to a lavish dinner to hear the spiel from one of their paid speakers. And without the free food the docs would not show up. So what did the companies do? Tell the speakers, sorry, we can no longer uise your services?

Hardly. They started inviting nurses to the talks instead of doctors. You might think, well, that makes sense; the nurses often have some influence over what medications the docs prescribe so this is a good indirect way of influencing the physicians. But Gardiner Harris, who wrote this up for the New York Times, made it clear that that was not the drug company's angle.

The point was, the speaker-docs were the local high prescribers of the company's product. It was essential for the companies to reward them for their good behavior. They were going to go on paying them to speak, come hell or high water, even if they had to fill the seats with life-size cardboard cutouts of people. (Harris, by the way, also pointed out that Dr. Carlat needed a better agent. The Minnesota top speakers easily pull down $100K a year.)

I know nothing about Dr. Carlat's own practice. But it seems reasonable to conclude that somebody at Wyeth added up the numbers and figured out that if they paid him to speak about Effexor a couple of times a week, somebody might listen to him and somebody might not. But the bottom line was that Dr. Carlat himself was going to find it very hard to prescribe anything except Effexor to his depressed patients. And those extra scripts were worth a certain amount to Wyeth.

Ghostwriting, as I discuss in HOOKED, is one of the hardest practices at the medicine-Pharma interface to get a grip on. All parties to the transaction--the academic physician whose name appears as the author of the article; the medical writer who actually wrote the article; and the drug company that funded everything--either are paying good money, or are paid good money, not to talk about any of it. Yet if anything at all in the medicine-Pharma relationship ought to be an ethical no-brainer, this is it. It can never be right for people to lie, in print, in the pages of medical journals, about who did or did not write something. And for the academic physician, accepting money to put your name on an article you did not write, and henceforward listing that article in your curriculum vitae as if you had written it, has to be the slimiest of unprofessional behaviors.

For all these reasons, even brief anecdotes about ghostwriting are worth taking note of. Here are a couple (one thanks to Roy Poses' excellent Health Care Renewal blog-- see Links).

Most recently, Jean E. Sealey, professor emerita of physiology and biophysics at Weill Cornell Medical College, went public with an approach she had received to "write" a review on the new anti-hypertensive drug nebivolol (Forest Laboratories):

One of the commentators astutely asked why the Wall Street Journal placed this news item on its blog instead of doing an in-depth story in its print edition.

Going back a little ways, Danny Carlat, in his own excellent blog on psychiatry issues (http://carlatpsychiatry.blogspot.com/), reported on a paper for which one of the listed co-authors is Dr. C. Lindsay DeVane, Professor of Psychiatry and Vice Chair for research at the Medical University of South Carolina. The paper is a summary of a discussion that occurred as part of an "Expert Roundtable," and was published in the May 2007 issue of CNS Spectrums, where it was listed as eligible for CME credit:

Dr. DeVane told Dr. Carlat that this paper is a "piece of commercial crap" and that the views expressed there are not his. He had not read the final version before it was published. The article was written after the discussion by a medical writer hired by i3 CME and funded by Bristol-Myers-Squibb. Dr. DeVane told Dr. Carlat that he found the draft text, which he was shown, "inaccurate, simplistic." He did not say whether he requested or demanded the right to edit "his" article. Neither Dr. DeVane nor Dr. Carlat addressed the question of 1) why Dr. DeVane allowed his name to appear on this article if it is untrue with regard to his views on the subject; and 2) whether any money changed hands at any point in the process. (One would assume that Dr. DeVane was paid expenses plus an honorarium to speak at the symposium, at the very least).

Just by way of further illustration of how hard it is to get a handle on the ghostwriting issue, I recently told a colleague of mine, who spends a lot more time than I do hanging out with journal editors, that the highest amount that I had ever been able to find in print, for the sum paid to the academic "author" of a ghostwritten paper for the privilege of using his name, was $1000. My colleague merely snorted.

Friday, November 23, 2007

Alex Berenson wrote recently in The New York Times about the delay in reporting the results of the "Enhance" trial of the cholesterol-lowering drug, ezetimibe. His article contains a quick review course of most everything that is wrong with company sponsored clinical trials of drugs, in case you came in late.

Ezetimibe is currently sold by Merck and Schering-Plough, alone (as Zetia) and in combination with a statin drug (as Vytorin). The two drugs together sell about $4B annually. Ezetimibe's claim to fame is that it does not work like statins, so patients unable to tolerate statins can usually take it safely. It also is better at selectively lowering "bad" (LDL) cholesterol than statins alone. Proof that it lowered LDL was enough for the FDA to approve it. Yet there have been no trials demonstrating that ezetimibe, either alone or in combination, actually prevents serious disease or saves lives. (Lesson One) Three such trials are underway with results expected perhaps in 2010.

In the meantime, a lot has been riding on the Enhance trial, which is designed to measure the growth of atherosclerotic plaque ("hardening of the arteries") in patients taking only a statin vs. patients taking both the statin and ezetimibe. The thickness of plaque is still a "surrogate endpoint" rather than an actual disease outcome; but many believe that it's a reasonable predictor of whether the drug will actually work. Berenson reports that there is therefore considerable concern among cardiologists that the results of Enhance, initially expected to be presented in March 2007, will not be ready till March 2008.

The official word from the lead investigator, Dr. John Kastelein of Amsterdam, is that no one knows what the results are yet because no data have been released, and the data are still being analyzed. The delays were routine problems that arise when you have as huge a body of data as was generated by this trial. Kastelein strongly denied that there was anything fishy going on.

But besides this suggestion of normal delay, there were two worrisome features of Enhance reported by Berenson. First, it turns out that the companies have sole control of the data, and until they analyze it all and elect to release it, Kastelein himself has no way to access it. (Lesson Two.) Second, it turns out that the companies have decided to change the study's primary endpoint. Initially they had planned to focus attention on a combination of plaque thickness measuements at three different points in the carotid (neck) artery. They now intend to report as the primary endpoint the thickness at onely one point. (Lesson Three) This, they claim, will allow faster reporting of the results and will be just as reliable. They say that they will still report the three separate places in the carotid, but as a secondary and not as a primary endpoint.

Kastelein hinted in the interviews that he was personally not very happy with the change in endpoints. To determine that this was the right thing to do, the companies brought in an outside expert advisory panel. The panel concluded that the endpoint should be changed. The companies refuse to say who was on the panel. (Lesson Four)

Trial expert and industry critic Dr. Bruce Psaty is quoted by Berenson as highly critical of the endpoint shift. As a rule such a shift is very suspicious because it raises fears that you are deciding what counts as a successful trial result only after you know what some of the data show. It is analogous to hitting a bull's-eye with a bow and arrow by first shooting the arrow, then drawing the bull's-eye around the arrow wherever it happens to land.

So, in summary, here is the set of rules for drug companies as to how to make the scientific community--at least that part of it that has not been bought off with your consulting fees, speakers' fees, research funding, etc.-- most suspicious that you are pulling a fast one:

Seek to get your drug on the market before we know whether it actually makes us live any longer or prevents real disease.

Keep all the data under your strict control; don't even let the (so-called) lead investigator see it.

Change the primary study endpoint in the middle of the trial.

Keep all the processes as secret as possible at each step of the way.

Now, there may, in fact, be perfectly innocent explanations for all of this. (After all, Saddam Hussein turned out to have no WMDs.) Given the past track record of industry behavior in like circumstances, how many people are willing to bet in this case that the explanations are entirely innocent?

Berenson A. After a trial, silence. New York Times, Nov. 21, 2007: C1.

NOTE ADDED 11/26/07: I'm grateful for an e-mail from Matt Herper at Forbes who informs me that they got to the ENHANCE story first-- see:

In one way this is old news because it adds to the long list of papers documenting that studies funded by drug companies turn out very often to conclude that the company's drug is best. But this paper extends the findings to a particular class of studies, those comparing one statin with another--the coveted head-to-head trials that we say the industry funds far too few of. And especially the paper gives us new insights into how the bias creeps in. (Or, in this case, the bias does not creep in; it walks right in the front door, sits down, and demands dinner.)

Because statins are such big business, Bero et al. were able find 192 studies comparing one statin to another. No surprise--in almost all cases, the end result was that the sponsoring company's statin performed better than the competitor statin. The authors found a 20-fold increased likelihood that the actual results of the trial would favor the company's own statin, and a 35-fold increased likelihood that the study would end up recommending the company's own statin. Note those numbers--obviously, in many (almost half) of the papers in which the authors confidently recommended the company's statin, the actual study results did not support that recommendation. (This is a fairly usual finding for industry-sponsored studies--that almost always there's a blatant marketing message added in amongst the scientific reporting. A pox on the journal editors and reviewers who lack the gumption to insist that such messages be excised, since it takes no advanced biostatistical smarts to figure out when the study results don't support the recommendations.)

Of even more interest were the reasons why these studies showed such disproprotionate results. Bero et al. were able to identify almost all the study design factors that accounted for the results that favored the company's drug--in this set of studies, the big culprits were inappropriate dosing of the comparator drug, and incomplete blinding. It does not seem to extreme to say that in summary, when the study results of a company-sponsored trial end up favoring the company's drug, it happens because the study was deliberately designed from Day One to assure that their drug came out on top. Again this is no surprise for an industry that makes it more clear all the time that it views its so-called scientific research enterprise as nothing but an extension of the marketing department.

I am not sure just how this changes over time; but when I logged on, the discussion thread had to do with some reps sharing stories of how they had deliberately contaminated the food they brought into physicians' offices to "get even" with various people who gave them a hard time or who did not value their services. Others took issue with such behavior. One resident, who maintains his own blog, wrote to say that now he had yet another reason not to take any food from reps, thereby setting off a torrent of abuse from the reps directed at the resident, replete with suggestions as to with whom his wife was sleeping when he was on duty.

I was guided to this blog one time before by an in-the-know acquaintance, and after 10 minutes of reading gave up in disgust. I chose at that time not to mention this blog or its contents in any of my writing on ethics and the industry, as it seemed way too cheap a shot to take at the reps as a group.

On this occasion as I read the postings I am struck by the range. Some of the reps seem thoughtful and decent and trying to maintain integrity. Others are embarrassingly juvenile, obscene, and just plain mean in their postings.I have tried hard in my own work never to villainize reps. As I see it, reps have an impossible job. From the company's point of view, they have one function only, to move product. I ask at every opportunity for someone to tell me about a single rep who was ever paid a single bonus for anything other than quantity of drug sales--and no one has ever given me an example.

The other part of their job is to lie about this. They have to lie to two people. First they have to lie to us, because we demand it. We will not easily and comfortably take all the goodies they shove our way, unless they keep repeating over to us the soothing rationalization, "It's education, not marketing." Second they often have to lie to themselves because they can live with themselves much easier if they can see themselves as educators and not as mere salespeople. Or at least they can lie to us more glibly if they lie to themselves first.

In one respect, I can concur completely with the blog postings, as much as I am repulsed by the packaging. If I sort through the obscenities, one basic idea seems to stand out. These reps despise docs and office staff who first scarf up their food and other goodies whenever they get the chance, and then believe that they can turn around the treat the reps who brought the stuff like dirt.

I agree totally. Whether that means it's ethical to deliberately sneeze in their lasagna is an issue we can take up at another time.

The article describes the same tale of woe--many of today's blockbuster drugs are about to go off patent; Pfizer for instance is looking to lose a cool $13 billion in annual revenue when Lipitor goes off-patent around 2010. The pipeline that was supposed to be producing the next generation of blockbuster drugs has suddenly dried up--notwithstanding heavy new investments in research by most of the leading companies. More and more of the drugs the companies have been relying on for revenues have developed safety problems, either before or after FDA approval.

In an odd turn of events, The Economist reports that even safe drugs are being axed by the companies when their sales are disappointing. Exubera, for example, Pfizer's inhaled insulin, has been one of those poor revenue performers, but has shown no safety problems. Nevertheless Pfizer CEO Jeffrey Kindler decided to pull Exubera around mid-October in a bid to cut costs. (Just what do you say to thousands of patients who have been taking your drug, presumably doing fine with it, and having no bad side effects, when you suddenly yank it off the market?)

One thing that's new, says The Economist, is that the industry leaders have stopped bluffing their way through this downturn. You can now hear such folks as Novartis CEO Daniel Vasella admit openly that the industry has to change its business model in a basic way, and can no longer thrive solely on its top-heavy marketing operation.

But just what is this new business model that will come along and save the industry? The article is pretty thin on those details. Drug firms are starting to buy up biotech firms and medical-diagnostics firms in hoping of adding research muscle and diversifying. Beyond that there is really no news here as to what the industry might have up its sleeve--if anything.

In HOOKED, at the end, I try to make a case that these industry woes might provide an opportunity for meaningful reforms, in the direction of enhanced medical professionalism, if the companies feel vulnerable and are willing finally to admit that they have a problem. Certainly if the only result of these bumps in the road is that the industry goes down the tubes, that would be an outcome that cannot possibly help anyone. Poetic justice may be emotionally satisfying but never made a sick patient better.

Campbell first notes legislative efforts at both Federal and state levels to require reporting of all company gifts to physicians. Then, after reviewing the reasons why marketing influence can harm patients' interests, he notes the increasing number of academic medical centers that have enacted strict policies banning drug reps and their gifts. He offers the opinion that maybe we are coming to a turning point when more and more physicians and medical centers will choose to divest themselves from the industry gravy train, and that either new laws, or the threat of them, might stimulate more aggressive internal measures by medical groups.

In the end Campbell offers some suggestions to individual practitioners, to "maximize the benefit for patients and minimize the risks associated with their own industry relationships."It may be worth assessing the value of these recommendations by comparing to material discussed in HOOKED:

Recognize that relationships with industry have one goal, to influence their prescribing behavior in industry-friendly directions, and assess the impact of these relationships on one's patients-- this is certainly good basic advice. I would add--all practitioners need to be regularly sensitized to the prevalent rationalizations that their colleagues use to justify the status quo and that industry sources are only too happy to reinforce vigorously: "it's education, not marketing"; "others may be influenced but I am a scientific reasoner and cannot be influenced"; "it's insulting to think that I can be boiught for a donut or a coffee mug"; and so on as we have extensively reviewed in this blog. After a while, no physician should be able to repeat these rationalizations without blushing.

Be familiar with policies and codes of ethics of one's medical institutions and professional societies-- this will be good advice for docs who happen to work for the forward-looking centers that have banned reps and their stuff. If the doc works for one of the majority that are not yet that enlightened, instiitutional policy won't help much. Ditto, as HOOKED shows, for most association codes of ethics. Most are based on now-discredited ideas that gifts are OK so long as they are of low monetary value, are "modest" meals, are aimed at patient care, and so forth.

Remember that ultimately the patients pay for all this junk--This also seems like good advice, and indeed, based on purely anecdotal evidence, this realization has provided the "aha!" moment for at least some physicians who ended up dissociating themselves from the reps' grip.

Thursday, November 1, 2007

In HOOKED I mentioned in passing that the drug industry claims that it spends more on research and development than on marketing, while virtually all independent economists put the figures at roughly 12% of revenues going to R&D while as much as 30% of revenues go to marketing. Besides that little white lie, the industry routinely pads its research numbers by slipping into the research column activities that really cannot be construed as research by any fair-minded criterion. The only specific example I was able to give, however, was "seeding trials"-- pretend post-marketing clinical trials which are really more disguised bribery, in which physicians are paid to give the drug to patients and to fill out meaningless "data" forms, the whole idea being to get practitioners to get used to prescribing the drug more and more.

I recently received from Donald Light, health systems professor at University of Medicine and Dentistry of New Jersey and an affiliate of the University of Pennsylvania Center for Bioethics, a copy of a recent book chapter he wrote. Among many other good things he provides a very handy list of these fake "research" budget items. Besides seeding trials, his list includes:

executive costs of negotiating with other firms for new product licensing

costs for medical writers and PR staff to write media stories about trials while they are in progress, to stimulate market demand

support for medical journal supplements and ads in those journals, as those are often the venue where lower-quality clinical trials can get published

lectures and CME courses to inform practitioners about current research

legal fees related to patents and licenses, and other research-related matters

land and construction costs for buildings in which some research is done, even if only a small amount of space is devoted to research

I cannot promise that each day I will issue an Integrity Award (let alone post a blog entry), but such as it is, today's award goes to Dr. Murad Moosa Khan, professor of psychiatry at Aga Khan University in Karachi, and author of "Why I declined an invitation to a drug company seminar":

There are several reasons why Dr. Khan seemed to merit special recognition:

He referred to the invitation to the seminar, at a 5-start hotel in Pakistan, as "a form of bribery" (see my other post today on that topic).

He is alert to the negative consequences of pushiong psychiatric drugs in his country, both for the patients who might be better served by a different form of treatment, and the excessive costs of the drugs that could better be invested elsewhere.

Dr. Khan emphasizes the social circumstances of psychiatric illness. He notes that most of his patients with the worst mental health problems are poor, and that Pakistan has no effective public policy for dealing with mental illness. He also berates the medical schools in Pakistan for failing to teach most physicians about any form of psychiatric management.

This 44 page report focuses on how drug marketing to physicians in the developing world seriously distorts health priorities. CI concludes that industry self-regulation is a flop, and calls for strict legal bans on "gifts" from drug companies to doctors in developing countries, with severe sanctions for violators.

ADDED 11/4/07: Here are a few more details from this important report. CI notes that most developing countries have effectively abandoned regulation of pharamceutical marketing to the industry. In turn, industry has blatantly violated many of its own claimed ethical codes. Advertisements to physicians in developing countries often leave out even the limited information that is required for the same drug in the developed world, and give blatantly misleading impressions about a drug. CI estimates that up to 50% of medicines in developing countries are irrationally prescribed. In these countries, people may pay a much larger percentage of their extremely limited health care dollars for medicines, so when an expensive drug does not work or is dangerous, the damage is doubled--both the direct effects of the drug, and the waste of money that could have been so much better spent on something else. While the amount of business done in the developing world by the major international drug companies is a small percentage of their total, this small sum is increasing much faster proportionally than most other sectors of the company's business, making it very tempting to keep on doing what drives the most profits. "Gifts" to physicians are often thinly disguised payoffs for the quantity of prescriptions written. Cars and televisions are not uncommon gifts received by high-prescribing doctors. (Popular gifts noted in a Pakistani survey included air conditioners, cars, cash, home appliances, and domestic cattle--the last a nice homey touch, don't you think?) Other popular gifts are air tickets, hotel and meal expenses to attend CME conferences, which are simply outside the affordability range of many practitioners in these nations without company funding.

CI notes that there are already laws and regulations against many of these practices; they need to be enforced. They call for a total ban on gifts; transparency in all industry marketing practices; and more government efforts at making CME and unbiased drug information available to their doctors.

A sad anecdote from Kenya--medical students have been spotted wearing white coats with drug company logos on them. When U.S. educators see residents going around with a lot of drug company pens and other gimmicks sticking out of all their pockets, they often try to shame them by asking, "Would you sell the company advertising space on your white coat?" In Kenya the answer seems to be "yes." CI reports that the same rationalizations that are in common usage among U.S. physicians to excuse taking company largesse are in evidence all around the world--only perhaps more understandable in nations where physicians are paid a relative pittance compared to their American income.

The point of this "progressive" website is all about framing. As linguist and Rockridge founder George Lakoff has written about for some time, political discourse in the US has deteriorated because one side of the political spectrum has been amazingly successful in framing many issues in such a way that the words used to describe the issue pre-determine the conclusions. There cannot be an honest political debate because one side of the issue never gets under the spotlight for discussion. For that reason we must be extremely careful of the language used to frame any policy discussion, and to be sure that it enhances rather than retards understanding of what is at stake.

Now, back to Pharma. I thought of the framing issue yesterday when two headlines came across the ether:

(Both these stories relate to the recent Consumers International report, which I will address in a second posting.)

Did you say "bribe"?

I thought--in HOOKED, I refer all the way through to "gifts" given to physicians by pharmaceutical companies. The companies themselves try not to go so far as even to say "gifts"--they call the small stuff with company logos, like pens and mugs, "branding items" or "reminder items," and they try to label all the big stuff as some sort of "education" or other.

These recent newspaper headline writers, apparently emboldened by the tough new report from Consumers International, had no problem calling the practice by a more proper, accurately descriptive name. (Dictionary.com tells us that "bribe (noun)" means: money or any other valuable consideration given or promised with a view to corrupting the behavior of a person, esp. in that person's performance as an athlete, public official, etc. All we have to establish for "gifts" from the drug industry to physicians to become "bribes" is that the commercial influence has the view of "corrupting" and that the behavior of a physician is analogous to that of a public official with regard to public trust. I offer arguments in HOOKED to show that those things are so.

So, if the goodies dangled before physicians by the drug companies are in fact bribes, why have we been giving them a free ride for so long and using euphemisms?

(I cannot help adding as a footnote that when I showed my wife the headline from The Guardian, her reply was: "So--they are not trying to bribe doctors who don't have cars?")